1. Field of the Invention
The present invention relates to minimally invasive medical procedures such as endoscopy and, more particularly, to an apparatus, kit and methods for suturing puncture sites or openings created in anatomical tissue for the introduction of instruments at internal operative sites.
2. Brief Description of the Related Art
Minimally invasive medical procedures such as endoscopy and, in particular, laparoscopy and thorascopy, have become preferable over invasive medical procedures for surgery and diagnosis. Invasive or open medical procedures typically involve the creation of a relatively large vertical or longitudinal incision in anatomical tissue of a patient to access an internal operative site. Minimally invasive or closed medical procedures such as endoscopic surgery and, in particular, laparoscopic and thorascopic surgery, involve the creation of one or more small size openings or puncture sites in anatomical tissue of a patient to provide access to an internal operative site for the introduction of various instruments to be used in the operative procedure to be performed. The puncture sites or openings are typically created by inserting a penetrating instrument through the anatomical tissue, the penetrating instrument typically including an obturator disposed within a portal sleeve. When the internal operative site is located within an anatomical cavity, such as the abdomen or thorax, the obturator is inserted through the tissue of an anatomical cavity wall so as to position a distal end of the portal sleeve within the cavity. In the case of laparoscopic and thorascopic surgery, the obturator is typically inserted through the cavity wall either before or after the abdominal or thoracic cavity is distended by insufflation gas to create increased space therein. The obturator enters the abdominal or thoracic cavity wall through the skin on an external side of the abdominal or thoracic cavity wall and exits the abdominal or thoracic cavity wall through the internal fascia and parietal peritoneum or pleura on the internal side of the abdominal or thoracic cavity wall, respectively, thusly forming a puncture site or opening through the abdominal or thoracic cavity wall. The portal sleeve extends through the puncture site or opening, which corresponds or substantially corresponds in size to the external diametric or cross-sectional dimension of the portal sleeve. Upon entry of the distal end of the portal sleeve in the abdominal or thoracic cavity or other anatomical cavity or area in which the internal operative site is located, the obturator is withdrawn from the portal sleeve leaving the portal sleeve in place in the puncture site or opening to establish communication with the internal operative site
One or more puncture sites or openings, each having a portal sleeve extending therethrough, can be created in the anatomical tissue or cavity wall in accordance with the number and/or type of instruments required to be introduced at the internal operative site for a particular operative procedure. Where more than one puncture site or opening is created in a patient, instruments can be introduced through the portal sleeves thereof such that more than one instrument can be present and used at the internal operative site simultaneously. Of course, it is also possible to introduce more than one instrument through a single portal sleeve so that such instruments can be present and used at the internal operative site sequentially and/or simultaneously. Exemplary instruments that may be introduced at an internal operative site through a portal sleeve or sleeves include remote viewing devices such as endoscopes or laparoscopes, grasping instruments, cutting instruments, cauterizing instruments, coagulating instruments, tissue retrieving instruments such as biopsy instruments, energy applying instruments, suturing instruments and ligating instruments which may be used individually or simultaneously during the operative procedure. Once the operative procedure has been completed, the one or more portal sleeves are withdrawn from the anatomical tissue or cavity wall, and the one or more puncture sites or openings are repaired or closed.
Minimally invasive procedures have many advantages over open procedures including reduced trauma and pain for the patient, shorter hospital stays and recovery times, fewer post-operative complications, reduced morbidity, reduced medical costs and the ability to perform many minimally invasive procedures in non-hospital sites without the need for general anesthesia. However, a drawback to minimally invasive procedures involves the difficulty associated with closing or repairing the one or more puncture sites or openings upon withdrawal of the one or more portal sleeves therefrom at the conclusion of the operative procedure.
One conventional approach to puncture site closure has involved suturing only the external and intermediate tissue layers, such as the skin and subcutaneous tissue or fat, at the puncture site or opening and leaving the inner tissue layer or layers, such as the internal investing fascia and wall musculature, unsutured such that an internal defect remains in the tissue. Where the puncture site or opening has been created to receive a portal sleeve 10 mm or less in diameter, the inner tissue layer or layers will usually naturally seal or heal in due course and close the internal defect. However, in some cases, the internal defect will not naturally seal or heal itself or will seal or heal improperly resulting in post-operative complications such as herniation, risking subsequent strangulation of the bowel or other viscera, and/or fluid migration into internal tissue layers. Where the puncture site or opening has been created to receive a portal sleeve greater than 10 mm in diameter, the relatively large size of the opening increases the risk that the inner tissue layer or layers will not properly, naturally seal or heal to close the internal defect. Accordingly, it is necessary and/or desirable, if possible, to suture or otherwise approximate and secure the inner tissue layer or layers for healing, thusly insuring proper closure of a puncture site or opening.
Another prior approach to puncture site closure, therefore, has involved conventional suturing of the inner tissue layer or layers and, in particular, the internal investing fascia and/or muscle layers, with a conventional, curved suture needle carrying a length of suture material. This is extremely difficult to accomplish in many patients due to the limited room for access and maneuverability available in minimally invasive procedures. Conventional suturing of the inner tissue layer or layers is impeded by the overall depth of the opening or puncture site, which can be considerable in heavy or obese patients due to the considerable thickness or depth of the intermediate tissue layer or layers. For example, it may be necessary for several inches of subcutaneous tissue such as fat to be retracted in order to isolate the internal investing fascia and/or muscle layers in a heavy or obese patient. The internal investing fascia in a heavy or obese patient will thusly be recessed several inches below the external side of the cavity wall, making it difficult to manually manipulate the needle between the subcutaneous tissue and the fascia.
Regardless of the patient's weight, suturing of the inner tissue layer or layers is traumatic to the patient since the puncture site or opening must be enlarged, stretched or otherwise manipulated to provide access to the inner tissue layer or layers. Where suturing is used to close the internal investing fascia of the abdominal cavity wall, poor control of the needle entering the abdominal cavity may result in puncture of the bowel or other internal organs or structure and may result in inadvertent securement of the bowel or other internal organs or structure in the sutured fascial closure. Because the surgeon cannot directly visualize the exact position of the needle until after it has passed through the cavity wall into the anatomical cavity, several insertions of the needle may be necessary to place the needle at the optimal distance from the puncture site in order to grasp or stitch the appropriate amount of tissue. The needle used for suturing may be inadvertently dropped in the anatomical cavity, with the needle possibly becoming lost and/or damaging anatomical tissue or structure within the cavity. The needle may break during suturing, with possible loss of a needle fragment or fragments in the anatomical cavity and/or damage to tissue or structure within the cavity caused by the needle fragment or fragments. Suturing of the inner tissue layer or layers is tedious and time consuming for the surgeon and increases the time required to perform minimally invasive surgical procedures. Given the increasing use of minimally invasive procedures and the use of larger portal sleeves, the occurrence of complications associated with puncture site closure can be expected to increase.
Various apparatus and methods have been proposed to facilitate the closure of puncture sites or openings in minimally invasive procedures as represented by U.S. Pat Nos. 5,222,508 to Contarini, 5,304,184 to Hathaway et al, 5,320,632 to Heidmueller, 5,350,385 to Christy, 5,364,408 to Gordon, 5,368,601 to Sauer et al, 5,374,275 to Bradley et al, 5,391,182 to Chin, 5,403,329 to Hinchcliffe, 5,417,699 to Klein et al, 5,439,469 to Heaven et al, 5,462,561 to Voda, 5,470,338 to Whiffield et al, 5,476,469 to Hathaway et al, 5,478,353 to Yoon, 5,562,683 to Chan, 5,573,540 to Yoon, 5,586,986 to Hinchcliffe, 5,643,292 to Hart, 5,653,717 to Ko et al, 5,653,718 to Yoon, 5,700,273 to Buelna et al, 5,836,955 to Buelna et al, 5,836,956 to Buelna et al, 5,846,253 to Buelna et al and 5,860,990 to Nobles et al.
Many of the prior apparatus for puncture site closure utilize suture needles and suture material incorporated in complex mechanical structures that are physically cumbersome and/or operationally complicated. Furthermore, many of the prior apparatus and methods for puncture site closure require that the suture needles and/or other parts of the apparatus be introduced a significant distance or depth internally of the tissue being sutured. Accordingly, there is a significant risk that the suture needles and/or other parts of the apparatus will penetrate or injure internal organs or other structures. In addition, many prior apparatus and methods for puncture site closure present the risks of dropped, lost and/or broken suture needles. Many prior apparatus for puncture site closure cannot be used with a portal sleeve in place in the puncture site. Some prior apparatus for puncture site closure can only be used subsequent to removal of the portal sleeve and, therefore, in absence of a pneumoperitoneum, thusly increasing the risk of internal injury since the anatomical cavity will no longer be distended.
Prior apparatus and methods for closing puncture sites or openings in minimally invasive procedures generally require specially designed or customized suture needles or other equipment not normally found in operating rooms. Additionally, conventional apparatus for puncture site closure commonly require that the suture material be pre-loaded into an instrument or other device and/or that the suture material be preformed with loops and/or knots. Some prior apparatus for puncture site closure necessitate the use of anchors on the suture material. There is also a tendency with prior apparatus and methods for puncture site closure for the suture material to become inadvertently tangled during use. Prior apparatus for puncture site closure are not easily adjustable to accommodate different thicknesses of anatomical tissue and generally fail to provide for insertion of the suture material in the tissue at an optimal location for a particular tissue thickness. The efficacy of prior apparatus and methods for puncture site closure undesirably depends to a great extent on the individual skill or expertise of the surgeon such that consistently favorable results are not obtained therewith by surgeons of varying degrees of skill and experience.
Accordingly, the need exists for a simplified apparatus, kit and methods for puncture site closure that allow one or more inner tissue layers at a puncture site or opening to be closed via sutures placed in the one or more inner tissue layers while a portal sleeve is disposed within the puncture site or opening. The need also exists for an apparatus, kit and methods for puncture site closure wherein a suture is guided by a puncture site closure apparatus for placement in one or more inner tissue layers at an optimal location. There is also a need for an apparatus, kit and methods for puncture site closure wherein the puncture site closure apparatus is easily adaptable for different thicknesses of anatomical tissue to insure optimal placement of a suture in one or more inner layers of the anatomical tissue in accordance with the particular tissue thickness. An additional need exists for an apparatus, kit and methods for puncture site closure that are used in conjunction with conventional penetrating members or needles, conventional suture materials and conventional grasping instruments typically available in operating rooms. The need further exists for an apparatus, kit and methods for closing puncture sites wherein the distance or depth that the apparatus extends internally of the tissue being sutured is minimized to avoid injury to internal organs or other anatomical structures and wherein loss of needles or needle fragments is avoided. Yet a further need exists for an apparatus, kit and methods for puncture site closure capable of obtaining consistently favorable results by surgeons of varying degrees of skill and experience.